Bander S Alshammeri
Buraidah, Al-Qassim Region, 52391, Saudi Arabia
NCT Number: NCT07815353
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease associated with substantial morbidity and mortality, impaired quality of life, and healthcare costs. Medication adherence and appropriate self-management are important components of COPD management; however, patients' health beliefs and perceptions may influence their adherence to treatment and engagement in recommended health behaviours. This study aims to evaluate the impact of a pharmacist-led educational intervention based on the Health Belief Model (HBM) on medication adherence, quality of life, and direct healthcare costs among patients with COPD receiving care at Buraidah Central Hospital (BCH) in Al-Qassim Region, Saudi Arabia.
A quantitative, quasi-experimental pretest-posttest control-group design will be used. Eligible COPD patients will be non-randomly assigned to either an intervention group or a control group. The intervention group will receive structured, pharmacist-led HBM-based educational sessions in addition to routine care. In contrast, the control group will continue to receive standard care without additional educational input. Baseline assessments will include medication adherence using the 8-item Morisky Medication Adherence Scale (MMAS-8); quality of life and health status using the COPD Assessment Test (CAT); health beliefs using a structured HBM questionnaire; and direct medical costs obtained from the hospital clinical cost centre. The educational intervention will be delivered over six months, followed by post-intervention assessment using the same outcome measures.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Buraidah, Al-Qassim Region, 52391, Saudi Arabia
The HBM will guide the content and delivery of the pharmacist-led educational intervention. The intervention will address the six core constructs of the HBM:
The intervention will consist of structured face-to-face educational sessions conducted in the designated counselling room of the Pulmonary Department at BCH. Sessions will incorporate printed educational materials, lectures, counselling, practical demonstrations, motivational support, problem-solving strategies, and reinforcement of behavioural changes.
The educational programme will cover aspects of COPD management, medication adherence and appropriate medication use, COPD risk factors and complications, nutrition and preventive care, smoking cessation, barriers to recommended behaviours, cues to action, and strategies to improve patients' confidence in managing COPD.
Participants in the intervention and control groups will undergo pre-intervention assessments. Participants in the intervention group will subsequently receive the structured educational programme, while the control group will continue to receive standard care without additional educational input. Post-intervention assessments will use the same measurement instruments to allow within-group and between-group comparisons.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must:
Exclusion criteria
Participants will be excluded if they:
Participants in the intervention group will receive routine care together with structured pharmacist-led educational sessions based on the HBM.
The educational intervention will be conducted face-to-face during scheduled outpatient appointments in the designated counselling room of the Pulmonary Department.
The programme will be delivered from study months 4 to 9.
Educational sessions will include:
Time frame: Baseline and 6 months after initiation of the educational intervention.
Change in medication adherence Measurement Tool 8-item Morisky Medication Adherence Scale (MMAS-8), prevalidated Arabic version Medication adherence will be assessed using MMAS-8 at baseline and following completion of the intervention.
Time frame: Baseline and 6 months after initiation of the educational intervention.
Change in quality of life/health status Measurement Tool COPD Assessment Test (CAT), prevalidated Arabic version The CAT will be administered to participants in both groups at baseline and after completion of the intervention.
Time frame: Direct medical costs assessed during the pre-intervention baseline period and during the post-intervention follow-up period after completion of the six-month intervention.
Change in direct medical costs associated with COPD Direct medical cost data will be obtained from the clinical cost centre of BCH.
The costing analysis will include direct COPD-related healthcare resources such as:
Important Costing Specification The cost of delivering the educational intervention will not be included in the costing analysis.
The economic component of this study focuses on the direct cost of illness associated with COPD rather than the cost of implementing the educational intervention.
Time frame: Baseline and 6 months after initiation of the educational intervention.
Changes in patients' health beliefs will be assessed using a structured, prevalidated Arabic HBM questionnaire.
The questionnaire assesses:
Contact information is provided by the study sponsor or research team.
Bander S Alshammeri, MSc
CONTACT
Rabia Hussain, PhD, Lecturer
CONTACT
Rabia Hussain
Other
Impact of a Pharmacist-Led Health Belief Model-Based Educational Intervention on Medication Adherence, Quality of Life, and Direct Cost Among COPD Patients at Buraidah Central Hospital in Al-Qassim Region, Saudi Arabia: A Quasi-Experimental Design
Acronym: ECHO-COPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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